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Cabergoline for Episodic Migraine

NCT07072910 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-18

No results posted yet for this study

Summary

The goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the efficacy, safety, and tolerability of cabergoline for the prevention of episodic migraine in adults with 4-14 monthly migraine days (MMD). The main questions it aims to answer are:

1. Does once-weekly cabergoline (0.5 mg or 1.0 mg) reduce MMD compared to placebo?
2. What are the effects of cabergoline on headache severity, acute medication use, and patient-reported outcomes?
3. Is cabergoline safe to use in individuals with migraine?

Participants will:

Complete a 4-week baseline period to document migraine frequency and classify headache days.

Be randomly assigned to one of three treatment arms:

1. Cabergoline 0.5 mg/week
2. Cabergoline 1.0 mg/week
3. Placebo

Participate in a 12-week double-blind treatment phase, followed by a 12-week open-label treatment phase where all participants receive cabergoline (0.5 mg or 1.0 mg once weekly).

Record daily headache activity, acute medication use, and severity using an electronic diary.

Complete validated headache questionnaires and provide blood samples for biomarker analysis at baseline, week 12, and week 24.

The study also includes exploratory analyses of genetic predictors of treatment response and metabolic markers to assess the broader effects of cabergoline.

Conditions

Interventions

DRUG

Cabergoline 0.5 MG

Participants will receive cabergoline 0.5 mg as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. Participants who received cabergoline 0.5 mg during the double-blind phase will continue with the same 0.5 mg dose in the open-label phase.

DRUG

Placebo

Participants will receive placebo as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. In the open-label phase, these participants will transition to active cabergoline treatment, receiving either 0.5 mg or 1.0 mg once weekly, depending on their randomized allocation at the start of the open-label phase. The placebo tablets will be formulated to match the cabergoline tablets in size, shape, and color, and should be taken under the same conditions.

DRUG

Cabergoline 1 MG

Participants will receive cabergoline 1.0 mg as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. Participants who received cabergoline 1.0 mg during the double-blind phase will continue with the same 1.0 mg dose in the open-label phase.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2028-03-01
Completion
2028-09-01

Countries

  • Denmark

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072910 on ClinicalTrials.gov